News

GE Healthcare, the health business of General Electric, announced on 7 March 2012 that it had reached an agreement to acquire biologicals manufacturer Xcellerex.

According to researchers at Frost & Sullivan, the European market for biosimilars will experience strong growth in the coming years due to patent expiries of blockbuster biologicals between 2010 and 2017. Cost containment strategies being implemented by governments and healthcare service providers are also given credit for shifting sales towards cheaper biosimilars.

Pfizer, the world’s largest pharma company, and Indian biosimilars major Biocon announced on 12 March 2012 that they had decided to end their biosimilar insulin deal due to ‘differing priorities’.

Contract research organisations (CROs) Celerion and Ricerca Biosciences announced on 29 February 2012 the formation of an integrated service solution for the development of biosimilar products.

FDA issued its long-awaited guidance for biosimilar applications on 10 February 2012 in the form of three draft guidance documents [1]. In a webinar on 15 February 2012 FDA discussed some of the issues surrounding biosimilar products and expanded on some of the requirements contained within the guidance documents.

The US pharmaceutical industry plays a vital role in shaping the face of American health care. With major patent expiries and thin product pipelines, the industry is now considering new directions to maintain growth and stability. Biological drugs, derived from living organisms, represent a growing opportunity for big pharmaceutical firms. They command high prices, will probably have fewer firms making them than generics due to high barriers to entry, and play to the existing strengths of big pharma firms. But will the recent healthcare legislation provide the way for consistent FDA regulation? What is the most likely way in which biologicals will enter the market over the next few years?

South Korean biotechnology company Celltrion announced on 1 February 2012 the successful completion of the company’s clinical programme for its (CT-P13) biosimilar of Johnson & Johnson’s rheumatoid arthritis blockbuster Remicade (infliximab).

Dutch-based bioanalysis specialist Spinnovation Biologics (Spinnovation) announced on 24 January 2012 that it had entered into a collaboration with US-based consulting company Quantum Tessera.

US generics manufacturer Watson Pharmaceuticals announced on 26 January 2012 that Amphastar Pharmaceuticals and Watson had been granted their request for a stay of the preliminary injunction preventing the companies from marketing or selling Amphastar’s enoxaparin sodium injection.

According to reports on Press TV— 24-hour English language global news network owned by the state-owned media corporation Islamic Republic of Iran Broadcasting— Iran is making significant advances in biosimilar and biotechnology drugs and is planning to start the production of 24 additional biosimilar drugs by the end of 2012.